Product News and Recalls

FDA Warns of Epidural Corticosteroid Injection Risks

The United States Federal Food and Drug Administration recently issued a warning regarding epidural corticosteroid injections and the risk of serious adverse medical events. Corticosteroids are a class of synthetic drugs that are used to reduce inflammation and are often used in pain-management situations. The procedure at issue involves injecting these drugs into the epidural space, the area around the spinal cord. While the FDA has never approved the use of corticosteroids for use in the epidural space, epidural corticosteroid injections have become a commonplace “off-label” practice in treating spinal nerve irritation that causes neck and back pain, as well as pain that radiates into a person’s limbs.

What Conditions do Epidural Corticosteroid Injections Treat?

Some of the more common medical issues that can cause nerve irritation include a herniated or bulging disc, bone spurs, joint cysts, or a slipped disc. The procedure is performed by placing a needle into the epidural space and injecting the corticosteroid into the affected area. Generally, the needle is guided using fluoroscopic guidance, and a contrast dye injected prior to the steroid in order to ensure that the needle is positioned correctly.

Epidural Corticosteroid Injection Side Effects

According to the FDA, epidural corticosteroids may result in serious side effects, including loss of vision, stroke, paralysis, and even death. Due to the potential severity of these side-effects, the agency has required that a warning label be added to injectable corticosteroids. In addition, the FDA recommends that patients discuss these risks and the risks associated with alternative treatments with their healthcare providers. Some of the corticosteroids used in epidural injections include hydrocortisone, triamcinolone, betamethasone, and dexamethasone.

People who are injured by epidural corticosteroid injections may suffer significant economic and non-economic losses. Fortunately, these losses may be compensable by filing a lawsuit against the drug manufacturer. As with any drug on the market, manufacturers are responsible for providing consumers with a safe product, as well as adequately warning consumers about the drug’s risks.

Attorney advertising. Attorneys at Lopez McHugh LLP are licensed in Pennsylvania, California, New Jersey, and New York. We may associate with attorneys from other states. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers. Past results are not a guarantee of future performance. Further, attorneys at Lopez McHugh LLP are not certified as specialists in any field. The hiring of a lawyer is an important decision that should not be based solely upon advertisements. The information on this page is provided for informational purposes only and is not intended to express or constitute legal or medical advice to any reader, may not apply to your specific factual or legal circumstances and may not be complete or up-to-date, nor does it create an attorney-client relationship. You should always consult directly with a qualified attorney for legal advice. Free consultation: In most cases, we represent clients on a contingency fee basis. This means that there is no up-front cost, but we will be reimbursed for expenses and charge a fee in the event that we receive a recovery on your behalf. If you agree in writing to hire us, we will make reasonable efforts to contact you when necessary. You, however, have an obligation to provide current contact information and to communicate with us so that we can properly investigate and, where appropriate, pursue your claim.